BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1222723 · Received November 10, 2008

    Report

    Report Number
    1628664-2008-00254
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 19, 2008
    Report Date
    October 20, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: ABERRANT DUE TO SAMPLE INTEGRITY / PREPARATION ISSUE. A SINGLE SAMPLE GENERATED AN INCONSISTENT LOW SODIUM (NA) RESULT ON A C8000. BUBBLES WERE NOTICED ON THE SURFACE (MENISCUS) OF THE PRIMARY SAMPLE TUBE, AND REPEAT TESTING GENERATED CORRECT RESULTS. THERE IS NO MENTION OF PROBLEMS WITH ANY OTHER SAMPLES, QUALITY CONTROL OR SYSTEM PERFORMANCE. THE COMPLAINT HISTORY FOR THE CUSTOMER'S ANALYZER, (B)(4), FOUND NO RECURRENCE OF THE ISSUE. THE SYSTEM PRESSURE MONITORING (PM) LOGS ASSOCIATED WITH THE LOW NA RESULT INDICATE AN INCREASED PRESSURE DURING ASPIRATION AND DISPENSE COMPARED TO THE OTHER SAMPLES. HOWEVER, THE INCREASED PRESSURE DID NOT EXCEED THE THRESHOLD REQUIRED TO GENERATE A PM ERROR AND WAS PROBABLY CAUSED BY A SMALL PIECE OF FIBRIN. COMPLAINT AND TRENDING DATA DID NOT IDENTIFY AN ADVERSE TREND OR ISSUE FOR THE C8000 SYSTEM OR THE ICT MODULE. THE CURRENT RATE OF INCONSISTENT, ERRATIC, AND ABERRANT COMPLAINTS AND OCCURRENCES IS BELOW THE ESTABLISHED LIMITS FOR THE ARCHITECT CLINICAL CHEMISTRY SYSTEMS. LABELING IN THE ARCHITECT OPERATIONS MANUAL AND ICT PACKAGE INSERT IS SUFFICIENT WITH REGARD TO THE CUSTOMER'S ISSUE. NUMEROUS PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR THE CUSTOMER'S ISSUE ARE FOUND UNDER THE OBSERVED PROBLEM ERRATIC RESULTS, POOR PRECISION. BASED ON THE AVAILABLE INFORMATION, THE PROBABLE CAUSE OF THE LOW NA RESULT IS A SAMPLE INTEGRITY ISSUE SUCH AS A SMALL PIECE OF FIBRIN THAT AFFECTED THE ICT SAMPLE ASPIRATION AND/OR TESTING. NO OTHER SAMPLE OR PERFORMANCE CONCERNS WERE NOTED AND THE ISSUE DID NOT RECUR. THE INVESTIGATION DID NOT IDENTIFY A DEFICIENCY. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE ARCHITECT C8000 ANALYZER GENERATED A LOW SODIUM RESULT OF 107.4 MMOL/L ON ONE PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED AND GENERATED A SODIUM RESULT OF 138 MOML/L. THE PATIENT SAMPLE GENERATED A SODIUM RESULT OF 143.0 BY THE RADIOMETER ADL800 METHOD. THE INITIAL RESULT WAS NOT REPORTED. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1